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Canadian Pegvisomant Compassionate Study In Acromegalic Patients

Pfizer logo

Pfizer

Status and phase

Completed
Phase 4

Conditions

Acromegaly

Treatments

Procedure: Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT
Procedure: Medical History, demographics
Drug: Pegvisomant treatment
Procedure: MRI
Procedure: Sign and symptoms: questionnaire

Study type

Interventional

Funder types

Industry

Identifiers

NCT00151437
A6291017

Details and patient eligibility

About

The purposes of this study are: 1) to provide SOMAVERT for compassionate use to patients with acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the safety and tolerability of SOMAVERT.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects must have participated and completed the previous Pegvisomant studies or have shown to be unresponsive to other conventional therapies

Exclusion criteria

  • ALT/AST>3 times the ULN or have hepatic disease
  • have severe visual field loss, cranial nerve palsies or intracranial HTN that requires surgery to decompress the tumor
  • unwilling to self-administer the medication.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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